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RO7837195 · 1 trial · 1 indication
Clinical remission is defined as the Modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore of ≤ 1, rectal bleeding subscore of 0, and endoscopy subscore of ≤ 1.
| Arm | Type | Description |
|---|---|---|
| RO7837195 Dose Regimen 1 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 2 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 3 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Dose Regimen 4 | EXPERIMENTAL | Participants will receive RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases. |
| RO7837195 Matched Placebo/ RO7837195 | EXPERIMENTAL | Participants will receive RO7837195 matched placebo and RO7837195 per the pre-defined dosing regimen during the 12-week induction and 40-week active treatment extension phases, respectively. |
| Name | Type | Description |
|---|---|---|
| RO7837195 | DRUG | RO7837195 will be administered as per the schedule specified in the protocol. |
| RO7837195 Matched Placebo | DRUG | RO7837195 matched placebo will be administered as per the schedule specified in the protocol. |
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established at least 3 months * Moderately to severely active UC assessed by mMS * Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC Exclusion Criteria: * Prior extensive colonic resection,...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
RO7837195 is an investigational small molecule being developed for the treatment of moderately to severely active ulcerative colitis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
RO7837195 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with ulcerative colitis.
RO7837195 is in Phase 2 clinical development. It is an investigational drug and has not been approved for any use. A Phase 2 trial is currently recruiting participants with moderately to severely active ulcerative colitis.
RO7837195 is being studied in one Phase 2 trial, NCT06979336, which is recruiting 224 participants with moderately to severely active ulcerative colitis. The study is randomized, double-blind, and controlled, and is being conducted across multiple countries.
RO7837195 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for ulcerative colitis. The drug has not completed clinical development or received marketing authorization from regulatory agencies.